Orthofix recalls specific box plates due to locking screws failing to engage during surgery. Affected items have unique part numbers and UDI lots. Consumers should contact Orthofix for details.
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Orthofix is recalling sterile box plates that may have locking screws which don't properly engage during surgery. This could lead to improper fracture fixation if used in medical procedures.
The locking screws in these plates may not securely attach to the plates during surgical procedures. This could result in the plates failing to hold bones together properly, potentially causing complications after surgery.
Medical professionals using Orthofix box plates for fracture repair are most at risk. Patients receiving these plates as part of surgery may also be affected.
Check for the part numbers 003-F-18001 (18mm), 003-F-22001 (22mm), or 003-F-30001 (30mm) on the label. The UDI/lot numbers are 18056099647854, 18056099647878, or 18056099647892.
Reach out to Orthofix directly for specific guidance on affected items and next steps.
The recall is due to locking screws not properly engaging with the plates during surgery, which could lead to improper fracture fixation.
Affected part numbers are 003-F-18001 (18mm), 003-F-22001 (22mm), and 003-F-30001 (30mm).
Check the label for the part numbers listed above and the corresponding UDI/lot numbers.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2125-2018 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2125-2018 from Orthofix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
